Back to Trials
NCT06199570NARecruiting

Support for Cancer Patients Awaiting News

Hackensack Meridian Health

Start Date

5/1/2024

Completion Date

12/30/2026

Summary

This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).

Detailed Description

Cancer patients repeatedly undergo routine scans that inform their disease status and treatment. While awaiting the results, anxiety and uncertainty are elevated, which can negatively impact quality of life. Evidence-based stress management strategies have the potential to be useful during this unique time period, but require tailoring for this population and context. The goal of this study is to pilot test an adapted stress management program to help patients manage their anxiety while awaiting scan results. The program is a behavioral intervention that includes psychoeducation and stress management activities, delivered via a web platform to promote dissemination. In the Open Trial phase, the program will be field tested in a single-arm trial, using feedback to refine materials and procedures as needed before formal piloting. In the Pilot RCT phase, a small RCT will be conducted to test the intervention's feasibility and acceptability and to examine preliminary effects on anxiety and other secondary outcomes.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Adult (ages 18 and older) 2. Comfortable speaking, reading, and writing English without an interpreter 3. Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer) 4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2 5. Receiving ongoing care from collaborating clinics with regular scans 6. Receiving systemic treatment for lung cancer 7. Endorse appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study) 8. Willingness to use the study website Exclusion Criteria: 1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen) 2. Requires an interpreter for medical visits 3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis) 4. Currently enrolled in hospice 5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)

Interventions

BEHAVIORAL

Adapted Stress Management Program

BEHAVIORAL

Enhanced Usual Care

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Lung Cancer

Locations

Amanda Khoudary

Hackensack, New Jersey 07601

United States